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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular, General & Plastic Surgery
510(k) Number K854418
Device Name ROUND SUCTION DRAIN
Applicant
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Applicant Contact ROBERT BRENNAN
Correspondent
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Correspondent Contact ROBERT BRENNAN
Regulation Number878.4200
Classification Product Code
GBS  
Date Received11/04/1985
Decision Date 11/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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